Introducer for an iliac side branch device

ABSTRACT

An introduction arrangement for a fenestrated or branched stent graft ( 13 ) intended for deployment into the lumen of a vessel having a blind vessel extending from it. The introducer ( 1 ) has a distal end intended to remain outside a patient in use and a proximal end with a nose cone dilator ( 11 ) and an arrangement to retain the branched stent graft distally of the nose cone dilator. A sheath ( 15 ) on the introducer extends over the branched stent graft to the nose cone dilator. An indwelling catheter ( 22 ) extends from the distal end of the introducer and enters the fenestration or side arm and through to the nose cone dilator, the indwelling catheter has a guide wire ( 29 ) extending through it. The guide wire can be extended beyond the nose cone dilator in use before the sheath is withdrawn from the branched stent graft so that it can be snared from the contra-lateral artery.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. Ser. No. 13/181,249 filedJul. 12, 2011, which is a Division of U.S. Ser. No. 10/962,763, filedOct. 12, 2004, now U.S. Pat. No. 8,012,193, and claims priority toprovisional application Ser. No. 60/510,823 filed Oct. 14, 2003 and Ser.No. 60/601,485 filed Aug. 13, 2004, all of which are incorporated byreference herein in their entireties.

TECHNICAL FIELD

This invention relates to a medical device and more particularly to amedical device adapted for deployment of a stent graft within a human oranimal body.

BACKGROUND OF THE INVENTION

This invention will be generally discussed in relation to deployment ofa stent graft into an iliac artery where it is necessary to extend aside branch from a stent graft into an internal iliac artery but it isto be understood that the invention is not so limited and may relate toany body lumen in which such a deployment is required.

Throughout this specification the term distal with respect to a portionof the aorta, a deployment device or a prosthesis is the end of theaorta, deployment device or prosthesis further away in the direction ofblood flow away from the heart and the term proximal means the portionof the aorta, deployment device or end of the prosthesis nearer to theheart. When applied to other vessels similar terms such as caudal andcranial should be understood.

Stent grafts are used for treatment of vasculature in the human oranimal body to bypass a repair or defect in the vasculature. Forinstance, a stent graft may be used to span an aneurism which hasoccurred in or associated with the iliac artery. In many cases, however,such a damaged or defective portion of the vasculature may include abranch vessel such as an internal iliac artery. Bypassing such a branchvessel without providing blood flow into it can cause problems and henceit has been proposed to provide a side branch on a stent graft whichwhen deployed is positioned over the opening to the internal iliacartery and then another stent graft can be deployed through the sidebranch into the internal iliac artery to provide a blood flow path tothe internal iliac artery.

Generally, when deploying an endovascular stent graft into a body lumen,it is possible to obtain access to such a body lumen from each end ofthe lumen where necessary, thereby facilitating placement of a device inthe lumen. The internal iliac artery which extends from the common iliacartery below the aortic bifurcation is for all intents and purposes ablind vessel because there is no practical way of performing anendovascular minimally invasive procedure into that vessel other than byentry from the common iliac artery. The term blind vessel is used hereinto describe such a vessel.

There have been proposals to deploy a branched stent graft into thecommon iliac artery via a femoral artery from a femoral incision withthe branched stent graft having a side arm to extend into or at leastadjacent the internal iliac artery, however, the use of such devices isvery dependent upon favourable layout of the arteries and in many cases,access is extremely difficult. This invention proposes an alternativemethod for approaching the common iliac artery and a deployment deviceto enable such a method to be practised.

It is the object of this invention therefore to provide an improveddeployment device or at least to provide a physician with a usefulalternative.

SUMMARY OF THE INVENTION

In one form therefore, although this may not necessarily be the only orbroadest form, the invention is said to reside in an arrangement forintroducing a stent graft into an internal iliac artery, the arrangementhaving means to enable a guide wire to be extended so that it can besnared from a contra-lateral iliac artery so as to enable access to theinternal iliac artery via an aortic bifurcation from the contra-lateraliliac artery.

Generally it will be seen that by the use of such a device, thedeployment of a stent graft into the internal iliac is more favourablewhen approached from the aortic bifurcation because the geometry of thebranch between the common iliac artery and the internal iliac artery ismore favourable when approached from that direction.

In an alternative form, the invention is said to reside in an introducerdevice having arrangement for retaining a stent graft thereon, anindwelling catheter having a guide wire therethrough associated with theintroducer device, the indwelling catheter extending to the proximal endof the introducer device whereby the guide wire can be advanced beyondthe proximal end of the introducer device so that it can be snared.

By this arrangement, the guide wire can be extended beyond theintroducer device so that it can be snared from the contra-lateral iliacartery and drawn over the aortic bifurcation and down the contra-lateraliliac artery so that the guide wire can be used to enter the internaliliac artery from over the aortic bifurcation.

Preferably the stent graft is of a type which includes a fenestration ora branch extending therefrom and the indwelling catheter extends throughthe fenestration or branch whereby a deployment device for a side armcan be deployed over the guide wire, once snared, to enter thefenestration or branch so that the side arm can be deployed into andextending from the fenestration or branch.

In a further form, the invention is said to reside in an introductionarrangement for a branched stent graft intended for deployment into thelumen of a vessel having a blind vessel extending therefrom; thebranched stent graft having a main tubular body having a distal end anda proximal end with a main lumen therethrough, a side arm extending fromthe main body and having a side arm lumen therethrough and in fluidcommunication with the main lumen, the introduction arrangementincluding an introducer, the introducer having a distal end intended toremain outside a patient in use and a proximal end, the proximal endhaving a nose cone dilator and an arrangement to retain the branchedstent graft distally of the nose cone dilator, the branched stent graftbeing retained on the introducer and a sheath on the introducerextending over the branched stent graft to the nose cone dilator, anindwelling catheter extending from the distal end of the introducerthrough an introducer lumen in the introducer to the branched stentgraft; exiting from the introducer lumen at a distal end of the branchedstent graft and entering the distal end of the side arm through the sidearm lumen to the main lumen and extending out of the proximal end of thebranched stent graft to the nose cone dilator, the indwelling catheterhaving a guide wire extending therethrough, whereby the guide wire canbe extended beyond the nose cone dilator in use before the sheath iswithdrawn from the branched stent graft.

It will be noted that by this form of introducer and branched stentgraft assembly the indwelling catheter is external of the stent graftfor part of its extent but during deployment it is covered by theintroducer sheath.

It will be seen that by this arrangement, an introducer can beintroduced into an artery such as an iliac artery and before the stentgraft is exposed by retraction of the sheath the guide wire can beextended beyond the nose cone dilator to enable it to be snared from thecontralateral iliac artery and then the guide wire can be used as willbe discussed below for deployment of a leg extension or side arm stentgraft into the internal iliac artery.

Preferably the nose cone dilator has a longitudinal groove thereon toreceive the indwelling catheter.

The means to retain the branched stent graft on the introducer mayinclude trigger wires extending to the distal end of the introducer andrelease arrangements for separate release of the proximal and distalends of the stent graft from the introducer.

In a further form the invention is said to reside in an introducerdevice and a stent graft retained thereon, the stent graft comprising atubular body and a fenestration in the tubular body, an indwellingcatheter having a guide wire extending therethrough and associated withthe introducer device, the indwelling catheter extending through thestent graft and the fenestration and to the proximal end of theintroducer device whereby the guide wire can be advanced beyond theproximal end of the introducer device so that it can be snared and adeployment device for a side arm can be deployed over the guide wire,once snared, to enter the fenestration.

Preferably the stent graft has a proximal end and a distal end and theindwelling catheter extends outside of the stent graft distally of thefenestration and through the fenestration into the stent graft andtowards the proximal end.

The fenestration can includes a side arm extending therefrom towardseither the proximal or distal ends thereof. Alternatively the side armextending from the fenestration extends inside the stent graft towardseither the proximal or distal ends thereof.

The indwelling catheter can extend inside of the stent graft distally ofthe fenestration and through the fenestration out of the stent graft andtowards the proximal end thereof.

In an alternative form the invention is said to reside in anintroduction arrangement for a fenestrated graft intended for deploymentinto the lumen of a vessel having a blind vessel extending therefrom;the fenestrated stent graft having a main tubular body having a distalend and a proximal end with a main lumen therethrough, a fenestration inthe main body, the introduction arrangement including an introducer, theintroducer having a distal end intended to remain outside a patient inuse and a proximal end, the proximal end having a nose cone dilator andan arrangement to retain the fenestrated stent graft distally of thenose cone dilator, the fenestrated stent graft being retained on theintroducer and a sheath on the introducer extending over the fenestratedstent graft to the nose cone dilator, an indwelling catheter extendingfrom the distal end of the introducer through an introducer lumen in theintroducer to the fenestrated stent graft, exiting from the introducerlumen at a distal end of the fenestrated stent graft and entering thefenestration to the main lumen and extending out of the proximal end ofthe fenestrated stent graft to the nose cone dilator, the indwellingcatheter having a guide wire extending therethrough, whereby the guidewire can be extended beyond the nose cone dilator in use before thesheath is withdrawn from the fenestrated stent graft.

U.S. Pat. No. 5,387,235 entitled “Endovascular Transluminal ProsthesisFor Repair Of Aneurysms” discloses apparatus and methods of retaininggrafts onto deployment devices. These features and other featuresdisclosed in U.S. Pat. No. 5,387,235 could be used with the presentinvention and the disclosure of U.S. Pat. No. 5,387,235 is herewithincorporated in its entirety into this specification.

U.S. Pat. No. 5,720,776 entitled “Barb and Expandable Transluminal GraftProsthesis For Repair of Aneurysm” discloses improved barbs with variousforms of mechanical attachment to a stent. These features and otherfeatures disclosed in U.S. Pat. No. 5,720,776 could be used with thepresent invention and the disclosure of U.S. Pat. No. 5,720,776 isherewith incorporated in its entirety into this specification.

U.S. Pat. No. 6,206,931 entitled “Graft Prosthesis Materials” disclosesgraft prosthesis materials and a method for implanting, transplantingreplacing and repairing a part of a patient and particularly themanufacture and use of a purified, collagen based matrix structureremoved from a submucosa tissue source. These features and otherfeatures disclosed in U.S. Pat. No. 6,206,931 could be used with thepresent invention and the disclosure of U.S. Pat. No. 6,206,931 isherewith incorporated in its entirety into this specification.

PCT Patent Publication No. WO98/53761 entitled “A Prosthesis and aMethod of Deploying a Prosthesis” discloses an introducer for aprosthesis which retains the prosthesis so that each end can be movedindependently. These features and other features disclosed in PCT PatentPublication No. WO98/53761 could be used with the present invention andthe disclosure of PCT Patent Publication No. WO98/53761 is herewithincorporated in its entirety into this specification.

U.S. Pat. No. 6,524,335 and PCT Patent Publication No. WO 99/29262entitled “Endoluminal Aortic Stents” disclose a fenestrated prosthesisfor placement where there are intersecting arteries. This feature andother features disclosed in U.S. Pat. No. 6,524,335 and PCT PatentPublication No. WO 99/29262 could be used with the present invention andthe disclosure of U.S. Pat. No. 6,524,335 and PCT Patent Publication No.WO 99/29262 is herewith incorporated in its entirety into thisspecification.

U.S. patent application Ser. No. 10/280,486, filed Oct. 25, 2002 andpublished on May 8, 2003 as U.S. Patent Application Publication No.US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 entitled“Prostheses For Curved Lumens” discloses prostheses with arrangementsfor bending the prosthesis for placement into curved lumens. Thisfeature and other features disclosed in U.S. patent application Ser. No.10/280,486, and U.S. Patent Application Publication No.US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 could beused with the present invention and the disclosure of U.S. patentapplication Ser. No. 10/280,486, and U.S. Patent Application PublicationNo. US-2003-0088305-A1 and PCT Patent Publication No. WO 03/034948 isherewith incorporated in its entirety into this specification.

U.S. Provisional Patent Application Ser. No. 60/392,682, filed Jun. 28,2002, U.S. patent application Ser. No. 10/447,406, filed May 29, 2003,and Published on Dec. 18, 2003, as U.S. Patent Application PublicationNo. US-2003-0233140-A1, and PCT Patent Publication No. WO 03/101518entitled “Trigger Wires” disclose release wire systems for the releaseof stent grafts retained on introducer devices. This feature and otherfeatures disclosed in U.S. Provisional Patent Application Ser. No.60/392,682, U.S. patent application Ser. No. 10/447,406, and U.S. PatentApplication Publication No. US-2003-0233140-A1, and PCT PatentPublication No. WO 03/101518 could be used with the present inventionand the disclosure of U.S. Provisional Patent Application Ser. No.60/392,682, U.S. patent application Ser. No. 10/447,406, and U.S. PatentApplication Publication No. US-2003-0233140-A1, and PCT PatentPublication No. WO 03/101518 is herewith incorporated in its entiretyinto this specification.

U.S. Provisional Patent Application Ser. No. 60/392,667, filed Jun. 28,2002, and U.S. patent application Ser. No. 10/609,846, filed Jun. 30,2003, and Published on May 20, 2004, as US Patent ApplicationPublication No. US-2004-0098079-A1, and PCT Patent Publication No. WO2004/028399 entitled “Thoracic Deployment Device” disclose introducerdevices adapted for deployment of stent grafts particularly in thethoracic arch. This feature and other features disclosed in U.S.Provisional Patent Application Ser. No. 60/392,667, U.S. patentapplication Ser. No. 10/609,846, and US Patent Application PublicationNo. US-2004-0098079-A1, and PCT Patent Publication No. WO 2004/028399could be used with the present invention and the disclosure of U.S.Provisional Patent Application Ser. No. 60/392,667, U.S. patentapplication Ser. No. 10/609,846, and US Patent Application PublicationNo. US-2004-0098079-A1, and PCT Patent Publication No. WO 2004/028399 isherewith incorporated in its entirety into this specification.

U.S. Provisional Patent Application Ser. No. 60/392,599, filed Jun. 28,2002, and U.S. patent application Ser. No. 10/609,835, filed Jun. 30,2003, and published on Jun. 3, 2004, as U.S. Patent ApplicationPublication No. US-2004-0106978-A1, and PCT Patent Publication No. WO2004/002370 entitled “Thoracic Aortic Aneurysm Stent Graft” disclosestent grafts that are useful in treating aortic aneurysms particularlyin the thoracic arch. This feature and other features disclosed in U.S.Provisional Patent Application Ser. No. 60/392,599, U.S. patentapplication Ser. No. 10/609,835, and U.S. Patent Application PublicationNo. US-2004-0106978-A1, and PCT Patent Publication No. WO 2004/002370could be used with the present invention, and the disclosure of U.S.Provisional Patent Application Ser. No. 60/392,599, U.S. patentapplication Ser. No. 10/609,835, and U.S. Patent Application PublicationNo. US-2004-0106978-A1, and PCT Patent Publication No. WO 2004/002370 isherewith incorporated in its entirety into this specification.

U.S. Provisional Patent Application Ser. No. 60/391,737, filed Jun. 26,2002, U.S. patent application Ser. No. 10/602,930, filed Jun. 24, 2003,and published on Mar. 18, 2004, as U.S. Patent Application PublicationNo. US-2004-0054396-A1, and PCT Patent Publication No. WO 2004/002365entitled “Stent-Graft Fastening” disclose arrangements for fasteningstents onto grafts particularly for exposed stents. This feature andother features disclosed in U.S. Provisional Patent Application No.60/391,737, U.S. patent application Ser. No. 10/602,930, and U.S. PatentApplication Publication No. US-2004-0054396-A1, and PCT PatentPublication No. WO 2004/002365 could be used with the present inventionand the disclosure of U.S. Provisional Patent Application Ser. No.60/391,73, U.S. patent application Ser. No. 10/602,930, and U.S. PatentApplication Publication No. US-2004-0054396-A1, and PCT PatentPublication No. WO 2004/002365 is herewith incorporated in its entiretyinto this specification.

U.S. Provisional Patent Application Ser. No. 60/405,367, filed Aug. 23,2002, U.S. patent application Ser. No. 10/647,642, filed Aug. 25, 2003,and PCT Patent Publication No. WO 2004/017868 entitled “Asymmetric StentGraft Attachment” disclose retention arrangements for retaining onto andreleasing prostheses from introducer devices. This feature and otherfeatures disclosed in U.S. Provisional Patent Application Ser. No.60/405,367, filed Aug. 23, 2002, U.S. patent application Ser. No.10/647,642, filed Aug. 25, 2003, and PCT Patent Publication No. WO2004/017868 could be used with the present invention and the disclosureof U.S. Provisional Patent Application Ser. No. 60/405,367, filed Aug.23, 2002, U.S. patent application Ser. No. 10/647,642, filed Aug. 25,2003, and PCT Patent Publication No. WO 2004/017868 are herewithincorporated in its entirety into this specification.

U.S. patent application Ser. No. 10/322,862, filed Dec. 18, 2002 andpublished as Publication No. US2003-0120332, and PCT Patent PublicationNo. WO03/053287 entitled “Stent Graft With Improved Adhesion” disclosearrangements on stent grafts for enhancing the adhesion of such stentgrafts into walls of vessels in which they are deployed. This featureand other features disclosed in U.S. patent application Ser. No.10/322,862, filed Dec. 18, 2002 and published as Publication No.US2003-0120332, and PCT Patent Publication No. WO03/053287 could be usedwith the present invention and the disclosure of U.S. patent applicationSer. No. 10/322,862, filed Dec. 18, 2002 and published as PublicationNo. US2003-0120332, and PCT Patent Publication No. WO03/053287 areherewith incorporated in its entirety into this specification.

U.S. Provisional Patent Application Ser. No. 60/405,769, filed Aug. 23,2002, U.S. patent application Ser. No. 10/645,095, filed Aug. 23, 2003,and PCT Patent Publication Number WO 2004/017867 entitled “CompositeProstheses” discloses prostheses or stent grafts suitable forendoluminal deployment. These prostheses and other features disclosed inU.S. Provisional Patent Application Ser. No. 60/405,769, filed Aug. 23,2002, U.S. patent application Ser. No. 10/645,095, filed Aug. 23, 2003,and PCT Patent Publication Number WO 2004/017867, could be used with thepresent invention and the disclosure of U.S. Provisional PatentApplication Ser. No. 60/405,769, filed Aug. 23, 2002, U.S. patentapplication Ser. No. 10/645,095, filed Aug. 23, 2003, and PCT PatentPublication Number WO 2004/017867 are herewith incorporated in itsentirety into this specification.

BRIEF DESCRIPTION OF THE DRAWING

This then generally describes the invention but to assist with theunderstanding, reference will now be made to the accompanying drawingswhich show a preferred embodiment of the invention and a method by whichthe preferred embodiment of the invention may be used to deploy a stentgraft into the internal iliac artery.

In the drawings;

FIGS. 1 to 6 show the various stages of deployment of a stent graft on adeployment device into an iliac artery according to one embodiment ofthe present invention;

FIG. 7 shows a schematic view of a deployment device with a stent graftmounted thereon according to one embodiment of the invention;

FIG. 8 shows a schematic view of a deployment device with a stent graftmounted thereon according to an alternative embodiment of the invention;

FIG. 9 shows a further schematic view of the deployment device shown inFIG. 8;

FIG. 10 shows a stage of deployment of the stent graft as shown in FIGS.8 and 9 corresponding to the stage of deployment shown in FIG. 5 above;

FIG. 11 shows a schematic view of a deployment device with a stent graftmounted thereon according to a further embodiment of the invention;

FIG. 12 shows a side view of one method of proximal retention suitablefor the present invention;

FIG. 13 shows a cross sectional view of the arrangement shown in FIG.12;

FIG. 14 shows a side view of one method of distal retention suitable forthe present invention; and

FIG. 15 shows a side view of an alternative method of distal retentionsuitable for the present invention.

DETAILED DESCRIPTION

Now looking first at FIG. 7, the introducer with a stent graft mountedonto it according to one embodiment of the present invention is shownschematically.

The introducer 1 has a proximal end 9, a distal end 7, a nose cone 11with tip 31, a proximal region 2 to be introduced into a patient in use,a distal region 4 intended to remain outside a patient in use, and ahandle 19 in the distal region 4. The introducer 1 has an introducercatheter 3 having an introducer lumen 32 extending over a guide wirecatheter 5. The guide wire catheter 5 has a guide wire lumen 26,configured to receive a guide wire (not shown) and extends from thedistal end 7 of the introducer 1 to immediately distal of the nose conedilator 11. The nose cone dilator 11 may have a long forward taper 28and a shorter reverse taper 30 distal to the forward taper. A branchedstent graft 13 is disposed on the introducer 1 in the stent graftretention 10 region and is retained at its proximal end 8 by a retentionarrangement (not shown in FIG. 7, but see FIGS. 12 and 13 for oneexample of a proximal retention arrangement) onto the introducerimmediately distal of the nose cone dilator 11. The branched stent graft13 is retained at its distal end 23 by another retention arrangement(not shown in FIG. 7, but see FIGS. 14 and 15 for examples of a proximalretention arrangement) onto the introducer. A sheath/sleeve 15 operatedby a sheath/sleeve manipulator 17 is mounted on the introducer catheter3 and in the ready to deploy position the sheath/sleeve 15 extends overthe branched stent graft 13 to the nose cone dilator 11. As illustratedin FIG. 7, however, the sheath/sleeve 15 is withdrawn so that thebranched stent graft 13 is exposed to show detail of the assembly. Ahandle 19 at the distal end of the introducer catheter 3 enablesmanipulation of the introducer 1. An indwelling catheter 21 enters alumen (not shown) of the introducer catheter 3 at the handle 19 andexits from the proximal opening 12 of the introducer catheter 3 at thedistal end 23 of the branched stent graft 13. The introducer catheterhas a proximal end 34 disposed distally of the nose cone dilator 11 andis adjacent the distal end of the stent graft retention region 10.

The branched stent graft 13 has a substantially tubular main body 14with a main lumen 16 through the main tubular body 14 and a side lumen18 through the branch 25. The branched stent graft 13 may include aplurality of stents on the main body 14. As shown in FIG. 7, a proximalbody stent 22 and a distal body stent 24 are disposed on the maintubular body. The indwelling catheter 21 enters the lumen 18 of thebranch 25 from its distal end 26 through distal end opening and hence itpasses outside the main tubular body 14 of the branched stent graft 13before it enters the branch lumen. The indwelling catheter 21 then exitsfrom the main tubular body 14 adjacent the nose cone dilator 11 andextends along the side of the nose cone dilator 11 in a groove 27 in thesurface of the nose cone dilator 11.

As shown in FIG. 7, within the indwelling catheter 21, there is a guidewire 29. This guide wire 29 can be pushed through the indwellingcatheter so that it extends beyond the tip 31 of the nose cone dilatorso that it can be snared as will be discussed in relation to FIGS. 1 to6 showing one embodiment of the stent graft placement procedure.Preferably the tip 32 of the indwelling catheter is tapered around theguide wire 29 to prevent blood loss through the indwelling catheter 21.

Now looking at FIGS. 1 to 6, it will be seen that there is schematicallyillustrated a series of arteries within the human body, although asdiscussed earlier, the invention is not restricted to this particularapplication.

A descending aorta 40 extends down to an aortic bifurcation 42 fromwhich extend common iliac arteries 44 and 46. From each of the commoniliac arteries an internal iliac artery 48 and 50, respectively,extends. As discussed earlier, the internal iliac arteries 48 and 50cannot be practically accessed from their distal ends remote from thejunction with the common iliac artery.

As shown in FIG. 1, a guide wire 50 for the deployment device 52 hasbeen extended into a femoral artery via a femoral incision (not shown)and extended up beyond the aortic bifurcation 42 to the aorta 40. Theintroducer 1 has then been deployed over the guide wire with the nosecone dilator 11 extending nearly up to the aortic bifurcation. At thisstage, the sleeve 15 on the deployment device extends up to the nosecone dilator 11 but has been withdrawn slightly to expose the proximalend 32 of the indwelling catheter 21.

As can be seen in FIG. 2, the guide wire 29 from the indwelling catheter21 has been extended so that it extends up beyond the aortic bifurcationbut only a short distance up the aorta 40. A snare catheter 52 has beendeployed via the contra-lateral iliac artery 46 and by suitableradiographic techniques the loop 54 of the snare catheter 52 is used tocatch the guide wire 29.

FIG. 2A shows an alternative step in the process. I this step theindwelling catheter 21 and the guide wire 29 have been advanced togetherto the aortic bifurcation 42 and so that the indwelling catheter 21 isbeyond the nose cone dilator 11. The guide wire 29 is then advance sothat it can be snared by the loop 54 of the snare catheter. By thisalternative step the guide wire 29 is held more firmly and there is lesslikelihood that it will become entangled with the main guide wire 50.

As shown in FIG. 3, the guide wire 29 has been withdrawn through thecontra-lateral iliac artery 46 and the indwelling catheter 21 has beenadvanced over the guide wire so that it extends over the aorticbifurcation 42 and down the contra-lateral iliac artery 46. To assistthis process, the sheath 15 has been withdrawn to the distal end 23 ofthe branched stent graft 13 so that it is just distal of the proximalend of the introducer catheter 3. At this stage the branched stent graft13 is partially freed but is still retained by retention arrangements atat least the proximal and distal ends of the branched stent graft and ishence in an unexpanded or not fully expanded condition.

FIG. 4 shows the next stage of the process where a sheath 58 of asuitable size has been advanced over the guide wire 29 via thecontra-lateral artery and indwelling catheter 21 so that it enters theproximal end 60 of the branched stent graft 13. At this stage, theindwelling catheter and guide wire 29 still extends down the iliacartery 44 on the introducer 1 so that the sheath 58 can be manipulatedto successfully enter the proximal end of the branched stent graft sothat it extends towards and into the branch 25 on the stent graft 13. Atthis stage, the indwelling catheter 21 and guide wire 19 can bewithdrawn either from the contra-lateral iliac artery 46 or from theiliac artery 44 and another guide wire 62 introduced via the sheath 58.This guide wire 62 can then be manipulated so that it enters theinternal iliac artery 48.

As shown in FIG. 5, a further deployment device 63 can then beintroduced via the sheath 58 from the contra-lateral iliac artery 46 toextend out of the distal end of the branch 25 of the branched stentgraft 13 so that a leg extension 64 can be deployed to extend from thebranch 25 of the branched stent graft 13.

As shown in FIG. 6, the sheath 58 from the contra-lateral iliac artery46 can then be withdrawn and the release mechanisms at each end of thestent graft 13 can be released and the leg extension 64 released so thatthe branched stent graft with leg extension is then deployed in thecommon iliac artery.

The introducer 1 can then be withdrawn although in some situations itmay be desirable to leave the sleeve 15 in position so that furtherdeployment of a stent graft into the aorta such as a bifurcated stentgraft can be achieved through the sheath 15.

In summary therefore, the steps in the graft placement procedureaccordingly using the device of the present invention may be as follows:

-   -   1. Deploy an introducer into a femoral artery via a femoral        incision and extend the introducer up to the aortic bifurcation.    -   2. Withdraw the sheath to expose the proximal end of an        indwelling catheter associated with the introducer.    -   3. Advance an indwelling guide wire through the indwelling        catheter beyond the nose cone dilator of the introducer.    -   4. Introduce a snare catheter into the contra-lateral iliac        artery via a femoral route and snare the indwelling guide wire.    -   5. Withdraw the indwelling guide wire through the contra-lateral        iliac artery and advance the indwelling catheter around the        aortic bifurcation to protect the aortic bifurcation during        subsequent steps.    -   6. Withdraw the main sheath to expose the branched stent graft        but still have the branched stent graft retained at each of its        ends.    -   7 Deploy an auxiliary sheath over the indwelling guide wire up        the contra-lateral iliac artery and into the branched stent        graft via the proximal end of the branched stent graft.    -   8. Advance the auxiliary sheath into the short leg of the        branched stent graft via the indwelling catheter guide wire or        another guide wire which has been deployed through the sheath        which has been placed via the contra-lateral iliac artery.    -   9. Remove the indwelling catheter and indwelling guide wire.    -   10. Advance a guide wire through the auxiliary sheath via the        contra-lateral iliac artery and manipulate it into the internal        iliac artery. At this stage, it may be necessary to withdraw the        deployment device or rotate it slightly to guide the branch of        the branched stent graft towards the internal iliac artery.    -   11. Advance a short leg introducer with a leg stent graft over        the guide wire in the contra-lateral iliac artery and through        the auxiliary sheath and into the internal iliac artery.    -   12. Release the proximal distal ends of the branched stent graft    -   13. Release the leg stent graft from the short leg introducer or        balloon expand the leg stent graft.    -   14. Withdraw the contra-lateral iliac artery auxiliary sheath,        introducer and guide wire.    -   15. Withdraw the main introducer.

As discussed earlier it may be necessary or desirable to leave thesheath of the main introducer and/or the main guide wire to enabledeployment of further stent grafts within the aorta and aorticbifurcation.

Now looking at FIGS. 8 and 9, an introducer with a stent graft mountedonto it according to an alternative embodiment of the present inventionis shown schematically. The same reference numerals are used forcorresponding features to those of FIG. 7.

The introducer generally shown as 1 has an introducer catheter 3extending over a guide wire catheter 5. The guide wire catheter 5extends from the distal end 7 of the introducer 1 to immediately distalof the nose cone dilator 11 which is at the proximal end 9 of theintroducer. A fenestrated stent graft 70 is retained by a retentionarrangement (not shown) onto the introducer immediately distal of thenose cone dilator 11. A sleeve 15 operated by a sleeve manipulator 17 ismounted on the introducer catheter 3 and in the ready to deploy positionthe sleeve 15 extends over the stent graft 70 to the nose cone dilator11. As illustrated in FIG. 7, however, the sleeve 15 is withdrawn sothat the stent graft is exposed to show detail of the assembly. A handle19 at the distal end of the introducer catheter 3 enables manipulationof the introducer 1. An indwelling catheter 21 enters a lumen (notshown) of the introducer catheter 3 at the handle 19 and exits from theintroducer catheter at the distal end 23 of the stent graft 70.

The stent graft 70 has a substantially tubular body with a main lumenthrough the main tubular body and a fenestration 71. The indwellingcatheter 21 enters the fenestration 71 from outside the stent graft andhence it passes outside the main tubular body of the stent graft at thedistal end thereof, before it enters fenestration. The indwellingcatheter then passes through the main lumen of the stent graft to itsproximal end and exits from the main body adjacent the nose cone dilator11 and extends along the side of the nose cone dilator in a groove 27 inthe nose cone dilator.

Within the indwelling catheter 21, there is a guide wire 29. This guidewire 29 can be pushed through the indwelling catheter so that it extendsbeyond the tip 31 of the nose cone dilator so that it can be snared asdiscussed in relation to FIGS. 1 to 6 showing a stent graft placementprocedure. Preferably the tip 32 of the indwelling catheter is taperedaround the guide wire 29 to prevent blood loss through the indwellingcatheter.

FIG. 10 shows a stage of deployment of the stent graft as shown in FIGS.8 and 9 corresponding to the stage of deployment shown in FIG. 5 above.The same reference numeral are used for corresponding features to thoseof FIGS. 1 to 6.

Prior to the stage shown in FIG. 10 a guide wire 50 for the deploymentdevice 52 has been extended into a femoral artery via a femoral incision(not shown) and extended up beyond the aortic bifurcation 42 into theaorta 40. An introducer 1 has then been deployed over the guide wirewith the nose cone dilator 11 extending nearly up to the aorticbifurcation. At this stage, the sleeve 15 on the deployment deviceextends up to the nose cone dilator but has been withdrawn slightly toexpose the proximal end of the indwelling catheter 21. Next a guide wirefrom an indwelling catheter (not shown in FIG. 10) has been extended sothat it extends up beyond the aortic bifurcation but only a shortdistance up the aorta 40. A snare catheter has been deployed via thecontra-lateral iliac artery 46 and by suitable radiographic techniquesthe loop of the snare catheter has been used to catch the guide wire.The guide wire has then been withdrawn through the contra-lateral iliacartery 46 and the indwelling catheter has been advanced over the guidewire so that it extends over the aortic bifurcation 42 and down thecontra-lateral iliac artery 46. To assist this process, the sheath 15has been withdrawn to just distal of the fenestration 25 and stillcovering the distal end 23 of the stent graft 70. At this stage thestent graft 13 is partially freed but is still retained by a retentionarrangements at the proximal end 60 of the stent graft and by the sheathat the distal end. The exposed portion of the stent graft between theproximal end and the fenestration can expand although there may bediameter reducing ties (not shown) to restrict the amount of expansion.Next a sheath 58 of a suitable size has been advanced over the guidewire 29 and indwelling catheter 21 so that it enters the proximal end 60of the branched stent graft 70. At this stage, the indwelling catheterand guide wire 29 still extends down the iliac artery 44 on theintroducer 1 so that the sheath 58 can be manipulated to successfullyenter the proximal end of the branched stent graft 60 so that it extendstowards and into the fenestration 71 on the stent graft 70. At thisstage, the indwelling catheter 21 and guide wire 19 can be withdrawn,either from the contra-lateral iliac artery 46, or from the iliac artery44 and another guide wire 62 introduced via the sheath 58. This guidewire 62 can then be manipulated so that it enters the internal iliacartery 48.

As shown in FIG. 10, a further deployment device 63 has then beenintroduced via the sheath 58 from the contra-lateral iliac artery 46 toextend out of the fenestration 71 of the stent graft 70. The furtherdeployment device 63 carries a leg extension 64. The leg extension 64can be deployed to extend from the fenestration 71 of the stent graft70. The leg extension 64 can be a covered balloon expandable stent forinstance, which is carried on a balloon in the deployment device so thatit can be deployed and expanded with its proximal end retained in thefenestration and extending into the internal iliac artery 48.

Now looking at FIG. 11, an introducer with a stent graft mounted onto itaccording to an alternative embodiment of the present invention is shownschematically.

In this embodiment the stent graft 90 has a fenestration 94 in the wallof the stent graft 90 and an internal leg extension 92 extendinginwardly and toward the proximal end 74 of the stent graft 90 from thefenestration 94. The indwelling catheter 80 extends into thefenestration 94 and into the internal leg extension 92 and toward theproximal end 74 of the stent graft 90. The indwelling catheter 80 thenexits from the main body adjacent the nose cone dilator 82 and extendsalong the side of the nose cone dilator 82 in a groove 81 in the nosecone dilator 82.

FIGS. 8 to 11 show various embodiments of the present invention in astylised manner. It should be noted that the configuration with the mainsheath withdrawn completely off the stent graft but with the indwellingcatheter and guide wire in its initial position would not occur inpractice.

FIG. 12 shows a side view of one method of proximal retention suitablefor the present invention and FIG. 13 shows a cross sectional view ofthe arrangement shown in FIG. 12. The same reference numerals are usedfor corresponding features to those of FIG. 7 for corresponding items.

The guide wire catheter 5 extends to a nose cone dilator 11 and theproximal end of the stent graft 13 is retained onto the guide wirecatheter just distal of the nose cone dilator. Retention is by means ofa pair loops of suture material 101 each of which is engaged with atrigger wire 103 extending from an aperture in the guide wire catheter5. The loops are placed so that there is formed a smaller 105 and largerfold 107 of the stent graft 13 at its proximal end. The indwellingcatheter passes through the region defined by the larger fold 107 andtherefore when the sheath 58 (see FIG. 4) has been advanced over theguide wire then it can more easily enter the lumen of the stent graft.

FIG. 14 shows a side view of one method of distal retention suitable forthe present invention. The same reference numerals are used forcorresponding features to those of FIG. 7 for corresponding items. Inthis embodiment the distal end 23 of the stent graft 13 is retained ontothe guide wire catheter 5 just proximal of the deployment catheter 3 bymeans of a suture loop 109 engaged into the stent graft 13 and a loop oftrigger wire 111 extending from the deployment catheter 3. Removal ofthe trigger wire 111 when required will release the distal end 23 of thestent graft 13.

FIG. 15 shows a side view of an alternative method of distal retentionsuitable for the present invention. The same reference numerals are usedfor corresponding features to those of FIG. 7 for corresponding items.In this embodiment the distal end 23 of the stent graft 13 is retainedonto the guide wire catheter 5 just proximal of the deployment catheter3 by means a loop of trigger wire 113 extending from the deploymentcatheter 3 and passing through a portion of the stent graft 13. Removalof the trigger wire 113 when required will release the distal end 23 ofthe stent graft 13.

Throughout this specification various indications have been given as tothe scope of this invention but the invention is not limited to anyoneof these but may reside in two or more of these combined together. Theexamples are given for illustration only and not for limitation.

Throughout this specification and the claims that follow, unless thecontext requires otherwise, the words ‘comprise’ and ‘include’ andvariations such as ‘comprising’ and ‘including’ will be understood toimply the inclusion of a stated integer or group of integers but not theexclusion of any other integer or group of integers.

What is claimed is:
 1. A method of deploying a branched stent graft intoa body vessel having a main vessel, a first branch vessel extending fromthe main vessel, a second branch vessel extending from the main vessel,a bifurcation between the first and second branch vessels, and a thirdvessel extending from the first branch vessel and having an ostium, thebranched stent graft comprising a main body having a distal end and aproximal end with a main lumen therethrough, a branch extending from themain body between the main body distal end and the main body proximalend, the branch having a branch lumen therethrough in fluidcommunication with the main lumen and a distal open end, the methodcomprising: providing a first delivery device including the branchedstent graft, a removable sleeve disposed over the branched stent graft,a first guide wire catheter, a second guide wire catheter, and an outercatheter disposed over the first guide wire catheter and second guidewire catheter and disposed within the removable sleeve; wherein thesecond guide wire catheter extends through the outer catheter from adistal portion of the outer catheter, exits the outer catheter at aproximal end of the outer catheter, extends from distal of the distalopen end of the branch, extends outside and at least partially along themain body of the branched stent graft, then extends into the distal openend of the branch, extends through the branch lumen to the main lumen,and extends out of the main lumen at the main body proximal end;advancing a first guide wire into the first branch vessel and past thebifurcation of the bifurcated vessel; advancing the first deliverydevice with the branched stent graft over the first guide wire; aligningthe branched stent graft such that the distal opening of the branch isabove the third branch ostium; at least partially removing the removablesleeve from the branched stent graft; and releasing an end of the mainbody from the first delivery device.
 2. The method of claim 1 furtherincluding advancing an auxiliary sheath into the second branch vessel,over the bifurcation and into the branch of the branched stent graft. 3.The method of claim 2 further including advancing a third guide wirethrough the auxiliary sheath and into the branch of the branched stentgraft.
 4. The method of claim 3 further including advancing a seconddelivery device including a stent graft extension over the third guidewire, through the auxiliary sheath, into the proximal end of the mainbody, into the branch of the branched stent graft, and into the thirdbranch vessel.
 5. The method of claim 1, wherein a second guide wire isintroduced into the delivery device and the branched stent graft by wayof the second guide wire catheter.
 6. The method of claim 5 furtherincluding introducing a snare into the second branch vessel andadvancing the snare to proximate the bifurcation.
 7. The method of claim6 further including snaring the second guide wire with the snare.
 8. Themethod of claim 7 further including drawing the second guide wire intothe second branch vessel with the snare.
 9. The method of claim 1,wherein the second guide wire catheter extends from distal of the mainbody distal end of the branched stent graft to the branched stent graft.